Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion
Key facts
- Where
- Austin, United StatesSee the site
- Phase
- Phase 3
Where in United States
- Texas Cardiac Arrhythmia Institute, St. David's Medical CenterAustin, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Texas Cardiac Arrhythmia Research Foundation
- Trial code
- NCT07840365
- Record updated
- 5 October 2026
- Original description
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.Read full original descriptionShow less
Optimal Anti-Thrombotic Management Following Percutaneous Left Atrial Appendage Occlusion (INTEGRAL)
This randomized study was designed to compare two antithrombotic regimens (long-term half-dose apixaban vs long-term aspirin after 45-days of full-dose apixaban) after successful Watchman implantation.
Inclusion: • Men and women ≥18 years of age; Patients who underwent a clinically successful LAA closure procedure with a Watchman device (device implanted without procedural or bleeding complication) within a day or are scheduled to undergo the LAAO procedure; Paroxysmal, persistent, or permanent AF patients irrespective of prior antithrombotic treatment are eligible for randomization,; Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion: Two or more clinical characteristics at baseline (age≥80 years, body weight ≤60 kg, serum creatinine ≥1.5 mg/dL) requiring apixaban dosage adjustment; Mechanical heart valves or valvular disease requiring surgery or interventional procedure; Mandatory indication for dual antiplatelet therapy (e.g. recent stent) or single anti-platelet treatment (SAPT) (e.g. high coronary risk); Any contra-indication or known allergy to aspirin or clopidogrel or apixaban; Any mandatory indication for anticoagulation for a reason other than AF (e.g. Pulmonary embolism); Ongoing major bleeding or complicated or recent (<72hours) major surgery; Recent myocardial infarction (<6 weeks); Recent TE event (<6 weeks); Recent Intracranial bleeding (< 6 months); Prasugrel or ticagrelor concomitant use; Participating in an investigational drug or another device trial within the previous 30 days; High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical; Pregnancy or within 48 hours post-partum or breast feeding women; Patient under legal protection.